Report: India still lacks solid medical device regulation

It has been 13 years since Indian health authorities were directed to create a framework for medical device regulation, but only 23 of 5,000 product categories are currently regulated, according to a report from the Hindu BusinessLine. In 2005, a Chief Justice at the Bombay High Court overhearing a case involving drug-eluting stents was shocked to find out that there was no framework to regulate medical devices, and directed the Central and State regulatory bodies to create a an entity to regulate the devices, according to the report. On January 1 this year, the Indian gov’t implemented Medical Device Rules, but the implementation fell short of a 2015 promise from the then Minister of Chemicals and Fertilizers Ananth Kumar, which oversaw medicines and devices, according to the Hindu BusinessLine. “Devices are not medicines made from a homogeneous chemical batch with very long lifecycles but usually an assembly of precision-engineered components with an ever-evolving, innovative, short-term product lifecycle,” the Association for Indian Medical Device Industry’s Rajiv Nath said, according to the report. Patient safety is more complicated with devices than with pharmaceuticals, Nath added, saying that it is “a shared responsibility of the manufacturer, medical practitioners, product user and the regulator,” the Hindu BusinessLine reports. AdvaMed’s Abby Pratt echoed the need to separate medical devices from pharmaceuticals, adding that “there...
Source: Mass Device - Category: Medical Devices Authors: Tags: Regulatory/Compliance Source Type: news